Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Providing regulatory guidance to cross-functional partners developing global regulatory strategies for new and modified medical devices.
- Assist in the development of the regulatory strategies for new products and design changes - ensuring regulatory requirements for target markets are met.
- Preparing and submitting regulatory submission documents for US and OUS regulatory filings under minimal supervision for the EU and supporting outside of US (OUS) geographies.
- Represent Regulatory Affairs on assigned project teams through all phases of product development and communicate regulatory requirements.
- Prepare Technical Files /Design Dossier Change Notifications and Submissions (e.g. Documentary Audits under MDD/ MDR).
- Provide guidance and direction to ensure international product registration/licensing requirements are addressed and met before commercial release to maintain international product registrations.
- Responsible for ensuring compliance with all relevant quality system regulations including EU MDR Regulation ISO 13485:2016 21 CFR Part 820 and the Regulations applicable for MDSAP certification.
- Prepare documentation that is complete accurate and on time.
- Utilizing detailed in-depth understanding of regulations interprets regulations and provides regulatory guidance to product development teams.
- Actively participates in defining customer requirements product claims and target markets early in the product development lifecycle.
- Participates in audits and inspections of the company and its quality systems.
- Review marketing materials go-to-market strategies and other commercialization activities as required to ensure continued compliance with established product clearances; lead the development of the regulatory strategy for new claims and indications.
- Support domestic and international field corrective actions and adverse event reporting.
- Create and update departmental standard operating procedures (SOPs).
- Perform all activities in compliance with the Quality System ISO 13485 MDR MHLW CMDR and all other applicable regulations to ensure all requirements are met.
- All other duties as assigned.
Requirements:
- Bachelors degree in chemistry scientific or engineering discipline.
- 4 years of work experience in regulatory affairs in medical device biotech or pharmaceutical industry.
- Experience in regulatory submissions (i.e. writing/developing/preparing/creating submissions for medical devices (Q-Submission 510(k) IDE PMA Technical File Design Dossier).
- Regulatory Affairs Certification (RAC) preferred.
Employment Type
Full-time
